Manufacturing Process Specialist - Sligo, Ireland - AbbVie

Description

What you do, is what we need. Making a difference begins here. And takes all of us.

We are now recruiting an experienced Manufacturing Process Specialist to join our Biologics Manufacturing team in our Ballytivnan site in Co. Sligo.

Our Ballytivnan site is a global centre of excellence for design control and precision engineering in the production of drug delivery devices.

Reporting to the Manufacturing Manager, in this role you will support engineering in pharma operations in line with all safety, regulatory and organizational requirements, while providing technical leadership and direction for the Manufacturing department, being a Subject Matter Expert (SME) in the formulation, aseptic filling process & isolator technology.

So, if you are interested in the opportunity and want to learn more, please apply, and we will be in touch.

Key Responsibilities of your role;

• On site ownership of manufacturing equipment, process knowledge and technology
• Sourcing and procuring process equipment including technical oversight of procurement process.
• Provide technical support for the Manufacturing Process and Equipment
• Collaborate with technical groups and experts across the network, ensuring consistency of technical approach and technical standards to strive for best-in-class performance.
• Design and implement technical studies and programs as appropriate to support investigations and product improvements.
• Developing knowledge of new pharmaceutical manufacturing processes as required in line with company business objectives.
• Identification and project management of continuous improvement projects. Work closely with all leaders to monitor and where necessary implement improvement initiatives in line with continuous improvement philosophy.
• Continuously drive to improve processes for improved performance and cost reduction wherever possible.
• Establishing/confirming specifications for process parameters, process controls and equipment effectiveness.
• Establish and maintain statistical process control systems in collaboration with Manufacturing and Quality functions.
• Monitoring and analysis of process data during the manufacturing of drug product.
• Oversight of planning, executing, and reporting for all process related aspects of technology transfer projects.
• Support the introduction of new products and process to site, working alongside all functions.
• Lead teams on identifying root cause and corrective actions for process deviations utilising best practice problem solving and continuous improvement methodologies in collaboration with other functions.
• Assuming accountability for risk assessments, including hazards, for the health and safety of company employees and visitors.
• Develop and modify procedures as needed to support the manufacturing
• operation.
• Participate in process, equipment, and facilities validations efforts and
• projects implementations.
• Liasing with operations, quality and S&T to ensure equipment and process performance is maximized.
• Adhering to all relevant policies relating to Quality & Safety.
• Ensure successful external inspections, and Division and Corporate audits.
• Supervision of external contractors.

Education and Experience:

• Third level qualification in an engineering, science or technical discipline
• Minimum 3 years' experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry
• Demonstrated experience of technical writing of complex issues.
• Must have experience in taking a lead role in investigations.
• High level of technology experience required, broad experience across drug manufacturing technologies and dosage forms preferred.
• Good knowledge of quality systems both FDA and EU regulations as they relate to manufacturing, facilities and process engineering

So, are you ready to join our team?

Closing date for Applications is Friday 17th May 2024.

It's important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.